A Study of Parsaclisib in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | October 5, 2017 |
End Date: | May 2021 |
Contact: | Incyte Corporation Call Center (US) |
Email: | medinfo@incyte.com |
Phone: | 1.855.463.3463 |
A Phase 2, Open-Label, 2-Cohort, Multicenter Study of Parsaclisib, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma
(MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma
(MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Inclusion Criteria:
- Men and women, aged 18 years or older.
- Documented failure to achieve at least PR with, or documented disease progression
after, the most recent treatment regimen.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Exclusion Criteria:
- History of central nervous system lymphoma (either primary or metastatic).
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan PI3K
inhibitor.
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
transplant within the last 3 months before the date of first dose of study treatment.
- Active graft-versus-host disease.
- Liver disease: Subjects positive for hepatitis B surface antigen or hepatitis B core
antibody will be eligible if they are negative for HBV-DNA. Subjects positive for
anti-HCV antibody will be eligible if they are negative for HCV-RNA.
We found this trial at
24
sites
Philadelphia, Pennsylvania 19104
Phone: 215-662-3933
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-996-8400
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Phone: 734-232-2883
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
Phone: 312-942-5978
Click here to add this to my saved trials
4777 East Galbraith Road
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Phone: 513-751-2273
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-3148
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
500 East Central Avenue
Winter Haven, Florida 33880
Winter Haven, Florida 33880
Phone: 863-293-1191
Click here to add this to my saved trials
2811 Tieton Drive
Yakima, Washington 98902
Yakima, Washington 98902
Phone: 509-574-3535
Click here to add this to my saved trials